Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000549921
Ethics application status
Approved
Date submitted
11/10/2019
Date registered
11/05/2020
Date last updated
22/07/2022
Date data sharing statement initially provided
11/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of non-weight bearing following surgical intervention for lower limb fracture on frailty.
Scientific title
Effect of non-weight bearing following surgical intervention for lower limb fracture on frailty.
Secondary ID [1] 299511 0
None
Universal Trial Number (UTN)
U1111-1241-8054
Trial acronym
IFNOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 314772 0
Lower Limb Fracture 314773 0
Condition category
Condition code
Public Health 313102 313102 0 0
Health service research
Injuries and Accidents 313103 313103 0 0
Fractures
Musculoskeletal 313104 313104 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is an observational prospective cohort study aiming to determine whether a non-weight bearing post surgical management of lower limb fracture is associated with increased risk of frailty.

Patients that decide to participate in the study will be required to provide informed consent. After consent is obtained several questionnaires will be supplied, medical records will be reviewed and finally a physical test will be carried out.

Patients (community dwelling individuals above 65 years old with fractures to the lower extremities and undergoing surgery) will be allocated to one of three groups based on the clinical management prescribed by the treating surgeons and physicians:

- Non weight bearing (NWB):No weight can be placed on the operated leg. Therefore, assistive device such as walker or crutches is required.
- Partial weight bearing (PWB): Allows the patient to place half of their weight on the operated leg.
- Full weight bearing (FWB): Allows the patient to place all of their weight on the operated leg, there is no restrictions in the amount of weigth placed on the extremity, therefore, no assistive device is required.

Patients will have follow up appointments 6 weeks and 12 weeks post-surgery.

Each appointment will have a duration of approximately 1.5 hours.

As this is an observational prospective cohort study, clinical management prescribed by treating physicians will not be affected by the involvement of the patient in this study.
Intervention code [1] 315778 0
Not applicable
Comparator / control treatment
Control Group: Full Weight Bearing
Participants allocated in this group are participants that as per surgeon or physician assessments are able to walk without having a restrictive weight on the injured limb.
Control group
Active

Outcomes
Primary outcome [1] 321644 0
Frailty: assessed by the Rockwood's 60 point Frailty Index and Hand Grip Test
Timepoint [1] 321644 0
Baseline
6 weeks
12 weeks
Secondary outcome [1] 375731 0
Length of stay: assessed by the inspection of medical records and discharge summaries.
Timepoint [1] 375731 0
6 weeks
12 weeks
Secondary outcome [2] 375732 0
Rate of transfer to residential aged care facility: assessed by the inspection of medical records.
Timepoint [2] 375732 0
6 weeks
12 weeks
Secondary outcome [3] 375733 0
Mortality
Timepoint [3] 375733 0
6 weeks
12 weeks

Eligibility
Key inclusion criteria
• Community dwelling
• Age equal or greater than 65
• Admitted with fractures of lower extremities (hip, femur, tibia and fibula)
• Surgical intervention for lower extremity fracture.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with lower extremities fractures who are not considered for surgical management
• Nursing home residents
• Terminal illness
• Presence of known active malignancy
• Severe dementia, requiring full nursing care at home.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Due to lack of literature assessing the effect of weight bearing on frailty, power calculations were not possible. The desired overall sample size for this study is 300, considering that there is not a randomly allocation of patients to treatment. Therefore, with this sample size, it is expected that at least 30 participants are allocated to each group. Participants allocation to each group will not be equal.

30 patients per group would allow a detection of 0.7 standard deviations difference in frailty index and/or hand grip strength. Due to pilot study nature, it is expected that power of the study will be below 80%;

Patient data will be grouped according to management strategy; NWB, PWB and FWB. Baseline characteristic will be compared between groups. Primary and secondary outcomes at baseline, 6 weeks and 12 weeks will be compared between groups using non parametric test (pair-wise comparison of continuous variables using rank sum and Fisher’s exact for categorical variables).

Providing at least 20-30 non weight bearing patient are recruited, ANCOVA will be used for analysis of primary outcome at 6 and 12 weeks, adjusting for baseline value of the outcome. Appropriate transformations will be performed if required. If the sample size enable, linear regression will be used with adjustments for confounders. Secondary outcomes will be assessed using logistic regression (mortality and requirement for residential care within the study period) or negative binomial regression (length of stay) with adjustment for potential confounders.

Time to death will be analysed using Kaplan-Meier and Cox regression with adjustment for confounders if sufficient number of outcomes occur in each group.

Data will be analysed according to intention to treat. Additional analysis with be undertaken to investigate the effect of compliance on analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
26/03/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
3/06/2019
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
300
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14943 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 14944 0
Footscray Hospital - Footscray
Recruitment hospital [3] 14945 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 28227 0
3021 - St Albans
Recruitment postcode(s) [2] 28228 0
3011 - Footscray
Recruitment postcode(s) [3] 28229 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 304005 0
Other Collaborative groups
Name [1] 304005 0
Australian Institute of Musculoskeletal Science
Country [1] 304005 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Sunshine Hospital
176 Furlong Rd
St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 304177 0
None
Name [1] 304177 0
Address [1] 304177 0
Country [1] 304177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304498 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 304498 0
Ethics committee country [1] 304498 0
Australia
Date submitted for ethics approval [1] 304498 0
21/11/2018
Approval date [1] 304498 0
01/03/2019
Ethics approval number [1] 304498 0
HREC/44486/MH-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97158 0
Prof Gustavo Duque
Address 97158 0
The University of Melbourne
Level 3 WCHRE, Sunshine Hospital
176 Furlong Rd, St Albans
VIC 3021
Country 97158 0
Australia
Phone 97158 0
+61 3 83958212
Fax 97158 0
Email 97158 0
[email protected]
Contact person for public queries
Name 97159 0
Gustavo Duque
Address 97159 0
The University of Melbourne
Level 3 WCHRE, Sunshine Hospital
176 Furlong Rd, St Albans
VIC 3021
Country 97159 0
Australia
Phone 97159 0
+61 3 83958212
Fax 97159 0
Email 97159 0
[email protected]
Contact person for scientific queries
Name 97160 0
Gustavo Duque
Address 97160 0
The University of Melbourne
Level 3 WCHRE, Sunshine Hospital
176 Furlong Rd, St Albans
VIC 3021
Country 97160 0
Australia
Phone 97160 0
+61 3 83958212
Fax 97160 0
Email 97160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be available. Overall data presented in publications, seminars or presentations will be in a de-identified manner


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5274Study protocol  [email protected]
5275Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.